Cohort Study on Nutritional, Metabolic, and Volumetric Assessment After Pancreaticoduodenectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

44 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-01

Study Completion Date

2024-12-31

Brief Summary

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Periampullary malignant neoplasms are among the most lethal gastrointestinal tumors. They are usually diagnosed at advanced stages and require complex surgical treatment. Pancreaticoduodenectomy, the standard procedure for resectable cases, significantly impacts nutritional status, pancreatic function, and the structural integrity of the remaining pancreas. However, there are still significant knowledge gaps regarding the volumetric and molecular changes that occur postoperatively and how these changes interact with body composition, resting energy expenditure, and biochemical markers.

This prospective, controlled, cohort study aims to integrate clinical, nutritional, metabolic, molecular, and imaging data to investigate changes in the remnant pancreas and their associations with postoperative outcomes. The study is expected to provide novel insights to support personalized, evidence-based nutritional and metabolic care for patients undergoing pancreaticoduodenectomy.

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Detailed Description

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Periampullary malignant neoplasms are lethal gastrointestinal tumors that are often diagnosed at advanced stages and require complex surgical intervention. Pancreaticoduodenectomy, the gold standard for resectable disease, has profound effects on nutritional status, exocrine pancreatic function, and the structural integrity of the remaining pancreas. Despite recent advances, significant gaps remain in our understanding of the volumetric and molecular alterations that occur postoperatively and how these alterations interact with body composition, resting energy expenditure, and biochemical markers.

This is a prospective, longitudinal, controlled, clinical-translational cohort study. Data on clinical, nutritional, biochemical, and plasma parameters will be collected at three time points for the experimental group (preoperatively and 3 and 6 months after hospital discharge) and one time point for the control group. Plasma samples will be stored at -80 °C and analyzed using validated techniques, including multiplex assays, spectrophotometry, ELISA, and tandem mass spectrometry (LC-MS/MS) to detect inflammatory biomarkers (IL-1β, , IL-6, TNF-α, and MCP-1; oxidative markers (MDA, GSH, TAC, and FRAP); proteomic targets (HSP70, fibronectin, and laminin); and lipidomic profiles (ceramides, sphingolipids, and cardiolipins). Abdominal imaging (CT and/or MRI) will be processed using 3D Slicer software to estimate the volume of the remnant pancreas via three-dimensional segmentation.

Statistical analyses will be conducted in RStudio. We will apply mixed linear models (MLM and MLMG), incorporating fixed and random effects to account for intra- and inter-individual variability. Missing not-at-random data will be addressed using multiple imputation by chained equations (MICE), and pooled estimates will be calculated according to Rubin's rules. We will set statistical significance at p \< 0.05 with Holm-Bonferroni correction for multiple comparisons.

This integrative approach ensures methodological rigor, bias control, and robust inference. It has the potential to guide personalized, evidence-based nutritional strategies in the context of pancreatic cancer.

Conditions

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Periampullary Neoplasms Pancreatic Cancer Pancreaticoduodenectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Pancreaticoduodenectomy Group

Patients aged 18-80 years with periampullary malignant neoplasms undergoing pancreaticoduodenectomy (classic Whipple or pylorus-preserving). This group will be followed prospectively for nutritional, metabolic, molecular, and volumetric assessments at baseline (preoperative), 3 months, and 6 months after hospital discharge.

Pancreaticoduodenectomy

Intervention Type PROCEDURE

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving) performed as part of standard clinical care for patients with periampullary malignant neoplasms. This procedure is not assigned by the study protocol, but is the exposure of interest. The study observes nutritional, metabolic, molecular, and imaging outcomes at baseline (preoperative), and at 3 and 6 months after hospital discharge.

Control Group

Age- and sex-matched individuals without malignant gastrointestinal disease, selected among those undergoing routine upper gastrointestinal endoscopy with normal or nonspecific findings. This group will undergo a single-time evaluation for nutritional, metabolic, molecular, and imaging parameters.

No interventions assigned to this group

Interventions

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Pancreaticoduodenectomy

Pancreaticoduodenectomy (classic Whipple or pylorus-preserving) performed as part of standard clinical care for patients with periampullary malignant neoplasms. This procedure is not assigned by the study protocol, but is the exposure of interest. The study observes nutritional, metabolic, molecular, and imaging outcomes at baseline (preoperative), and at 3 and 6 months after hospital discharge.

Intervention Type PROCEDURE

Other Intervention Names

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Whipple procedure Pylorus-preserving pancreaticoduodenectomy

Eligibility Criteria

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Inclusion Criteria

* Adults aged between 18 and 80 years;
* Histologically or radiologically confirmed diagnosis of resectable periampullary malignant neoplasms (e.g., pancreatic head adenocarcinoma, ampullary carcinoma, distal cholangiocarcinoma, duodenal adenocarcinoma);
* Candidates for elective pancreaticoduodenectomy (either classic Whipple or pylorus-preserving technique), performed by the institutional surgical team following standardized protocols;
* ECOG Performance Status ≤2;
* Adequate cardiopulmonary function to undergo major surgery, as assessed preoperatively;
* Ability and willingness to provide written informed consent.

Exclusion Criteria

* Previous pancreatic surgery;
* Pancreaticoduodenectomy performed outside the study institution;
* Evidence of unresectable disease, distant metastases, or local tumor recurrence at baseline imaging or intraoperative assessment;
* Active inflammatory or autoimmune diseases (e.g., rheumatoid arthritis, lupus, inflammatory bowel disease);
* Active malignancy other than periampullary cancer, or history of non-pancreatic cancer within the past 5 years;
* Use of systemic immunosuppressive therapy (e.g., corticosteroids \>10 mg/day prednisone equivalent, chemotherapy, biologics);
* Diagnosed malabsorption syndromes unrelated to pancreatic disease;
* Severe hepatic dysfunction or severe renal impairment (eGFR \<30 mL/min/1.73m²);
* Pregnancy or breastfeeding;
* Refusal or inability to attend scheduled follow-up visits within 6 months;

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes